Patisiran (Onpattro)

Inotersen (Tegsedi®), patisiran (Onpattro®) and vutrisiran (Amvuttra®) are used in hereditary transthyretin amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy.

A Managed Access Protocol (MAP) is in place for these medicines. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of patisiran or vutrisiran under hospital pricing approval or inotersen on the High Tech Arrangement.

Applications for reimbursement approval for these medicines will only be considered from consultants registered with the Irish Medical Council, with experience in the diagnosis and management of hereditary transthyretin amyloidosis in specialist centre(s) in Ireland, who have agreed to the terms of this MAP and been approved by the HSE.

The approved consultant must submit an application for individual reimbursement approval for each patient. Applications for individual reimbursement approval or transferring reimbursement approval will only be considered from approved consultants.

A copy of the MAP for medicines used in hereditary transthyretin amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy and the relevant forms can be found in the Related Files section below.

For further information, please contact mmp@hse.ie.